Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age22-40
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

abnormal uterine NK cell function;

have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;

have clear fertility desires;

normal ovarian function or with frozen embryos;

Disqualifiers

using progesterone receptor modulator;

chromosomal karyotype abnormalities in one spouse;

severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;

uncontrolled autoimmune diseases;

Trial design

Design model

Single group

Treatments tested in this trial

  • autologous decidual-like NK cells

    Biological/Vaccine

    intrauterine infusion

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: autologous decidual-like NK cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Improvement rate of NK cells

Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells

Time frame
6 months after the first intrauterine infusion therapy

Secondary outcomes

1

Duration of improvement in NK cells

Duration of improvement in NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells

Time frame
6 months after the first intrauterine infusion therapy
2

Clinical pregnancy

Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity

Time frame
1 year after completion of NK cells therapy
3

Ongoing pregnancy

At least 12 weeks of pregnancy, ultrasound indicates that the fetus has cardiac activity and the size of the fetus matches the gestational age

Time frame
1 year after completion of NK cells therapy
4

Live birth

Delivery of any number of neonates born at 26 or more weeks' gestation with signs of life

Time frame
1 year after completion of NK cells therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

The University of Science and Technology of China

Collaborator